Clinical Research Associate - Remote

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.

ICON Government and Public Health Solutions is searching for a Clinical Research Associate II to support. These are full time permanent positions supporting GPHS headquarters within different therapeutic areas.

1. Assists Clinical Project Managers in project coordination, planning and logistics, including overview of budgets and timelines as needed.
2. Participates in project team meetings.
3. Assists the Project Managers with the follow up and resolution of action items, risk mitigation and Corrective and Preventative Action plans.
4. Works with the Project Managers to select qualified and experienced research sites. This includes feasibility questionnaire generation, site outreach, tracking of feedback and overall review of site responses/qualifications.
5. Provides training to CRAs (Basic orientation, CTMS, Protocol Specific).
6. Provides daily oversight of CRAs including co-monitoring for assessment and evaluation.
7. Develops clinical monitoring plans and assist in development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).
8. Assists CRAs and QA specialist in identification of site issues/problems, and associated root causes, and development action plans to ensure resolution, including escalation of appropriate issues in a timely manner.
9. Acts as the main line of communication between the sponsor and the CRA.
10. Reviews and approves monitoring reports and follow up letters.
11. Provides management of study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations.
12. Conducts monitoring visits as needed (Qualification, Site Initiation, Interim, Close-out, Audit Prep.)
13. Verifies that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study.
14. Verifies that the investigator and research staff follow the approved protocol and all GCP procedures.
15. Ensures adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF.
16. Communicates deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective action is implemented.
17. Reviews queries and assist in resolution.
18. Utilizes CTMS to generate, review and provide study reports.
19. Assists with setup, quality and maintenance of the Trial Master Files (TMF) in accordance to Clinical RM SOPs, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
20. Assists with the selection, communication and maintenance of project related vendors.
21. Performs ongoing reviews of the TMF to ensure quality of the documentation files and compliance with Clinical RM SOPs, GCP and ICH guidelines.
22. Assists the Project Management team in preparation for audits or inspections.
23. Works with the Project Managers to ensure all the required study documentation (agreements, site SOPs, etc.) have been obtained from the site prior to site initiation.
24. Participates in the department review of SOPs when needed.
25. Assists with protocol development and review as needed.
26. Provides technical assistance for proposal writing as needed.
27. Reviews Safety and Clinical Study Reports.

1. Bachelors’ degree or better, and Clinical research experience supporting a CRO company
2. 2 years of directly related clinical research associate experience or clinical trial management
3. 3 years of clinical research experience
4. Thorough knowledge of ICH GCP Guidelines, FDA Regulations and HIPAA.
5. Ability to travel 60-80%
6. Ability to work well in a team environment as well as independently as needed.
7. Ability to establish and maintain effective working relationships with coworkers, managers and customers
8. Must be able to work independently following a brief period of specific technical training.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.